Anoscope

ABSTRACT

An anoscope kit comprising an anoscope having a plurality of spaced apart fingers having free ends and a dilator removably positionable within the anoscope to aid insertion of the anoscope. The dilator has a proximal region, an intermediate region and a distal region, the distal region including an enlarged distal head. A ramped surface extends from the enlarged distal head toward the intermediate region, the intermediate region having an outer surface to contact the fingers of the dilator.

This application claims priority to provisional application Ser. No.61/120,926, filed Dec. 9, 2008, the entire contents of which areincorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to an anoscope for use in surgicalprocedures.

2. Background of Related Art

An anoscope is a device for providing access to the anal canal and lowerrectum. It is generally a tubular device that is inserted into the anusand dilates the anus to provide an access passage. In some instances,the anoscope provides a passage for a suturing device to apply pursestring sutures to the desired tissue. One common application is forhemorrhoid surgery where the hemorrhoid or adjacent tissue is accessedthrough the anoscope and purse stringed for subsequent clamping in acircular stapling device which resects and staples the tissue.

The need exists for an improved anoscope to enhance access to the analcanal and enhance application of purse string sutures for hemorrhoid orother surgical procedures.

SUMMARY

There is disclosed an anoscope kit having an anoscope and dilator. Theanoscope has a proximal portion, a distal portion, and a plurality ofspaced apart fingers having free ends. The dilator is removablypositionable within the anoscope to aid insertion thereof and has aproximal region, an intermediate region and a distal region. The distalregion of the dilator includes an enlarged distal head, and a rampedsurface extends from the enlarged distal head toward the intermediateregion. The intermediate region has an outer surface to contact thefingers of the anoscope.

In one embodiment, the fingers of the anoscope extend substantiallyparallel to a longitudinal axis of the anoscope and the free ends of thefingers extend substantially parallel to the longitudinal axis of theanoscope. In one embodiment, the free ends of the fingers lie insubstantially the same plane as an intermediate portion of the finger.

The anoscope may include a flange at the proximal portion. In apreferred embodiment, the transverse dimension of the anoscope at theregion of the fingers is substantially equal to a largestcross-sectional dimension of the distal head of the dilator.

The kit may further include a port dimensioned to receive the anoscope.

In one embodiment, the fingers extend inwardly towards a distal end suchthat a first transverse dimension of the anoscope adjacent a distal endof the fingers is less than a second transverse dimension of theanoscope at a proximal end of the fingers. In this embodiment,preferably the transverse dimension of the enlarged head is greater thanthe first dimension and less than the second dimension.

The present disclosure also provides in combination an anoscope anddilator wherein the dilator has a distal head forming an enlarged headregion, an intermediate region having an outer surface configured toabut fingers of the anoscope, and a transition surface from the distalhead to the intermediate region. The anoscope has a plurality of fingersseparated to form gaps therebetween, a portion of the fingersdimensioned to lie on the transition surface and on the intermediateregion of the dilator.

In a preferred embodiment, a distal tip of the fingers lies on thetransition surface of the dilator. In one embodiment, the transitionsurface is a ramped surface. The distal tips of the fingers have anangled surface engaging the ramped surface of the dilator when thedilator is positioned within the anoscope.

The anoscope may include an enlarged proximal region creating a stop forinsertion of the anoscope into the anal canal.

The present disclosure also provides a method of inserting an anoscopeinto a patient comprising the steps of:

providing a dilator having an enlarged dilating distal head forming alip;

providing an anoscope having a plurality of fingers extendingsubstantially parallel to a longitudinal axis of the anoscope;

inserting the dilator into the anoscope; and

advancing the dilator and anoscope into an anal canal of the patientwherein distal tips of the fingers abut the lip of the dilator tothereby reduce flexing of the fingers during anoscope insertion.

DESCRIPTION OF THE DRAWINGS

Embodiments of the presently disclosed anoscope and dilator aredisclosed herein with reference to the drawings, wherein:

FIG. 1 is a perspective view of one embodiment of an anoscope anddilator of the present disclosure showing the dilator positioned withinthe anoscope;

FIG. 2 is a perspective view of the anoscope and dilator prior toinsertion of the dilator within the anoscope;

FIG. 3 is a cross-sectional view illustrating the dilator within theanoscope positioned within the anal canal;

FIG. 4 is a cross-sectional view similar to FIG. 3 showing initialwithdrawal of the dilator from within the anoscope;

FIG. 5 is a cross-sectional view similar to FIG. 4 showing the dilatorfurther withdrawn from the anoscope;

FIG. 6 is a cross-sectional view similar to FIG. 5 showing the dilatorbeing withdrawn from the anoscope;

FIG. 6A is a cross-sectional view of an alternate embodiment of thedilator and anoscope showing the dilator positioned within the anoscope;

FIG. 7 is a perspective view of a port for optional use with theanoscope of the present disclosure; and

FIG. 8 is a side view in partial cross section of a surgical stapler.

DETAILED DESCRIPTION OF EMBODIMENTS

The anoscope kit of the present disclosure will now be described indetail with reference to the drawings wherein like reference numeralsdesignate identical or corresponding elements in each of the severalviews. As is common in the art, the term ‘proximal” refers to that partor component closer to the user or operator, i.e. surgeon or physician,while the term “distal” refers to that part or component further awayfrom the user.

It should be appreciated that the anoscope can be used in a variety ofsurgical procedures. Such procedures include, for example, the treatmentof colon prolapse and hemorrhoids.

Some of the procedures, such as hemorrhoid procedures, requireapplication of a purse string suture to the hemorrhoids. In otherprocedures, such as hemorrhoidopexy, a purse string suture is applied totissue adjacent the hemorrhoids. The anoscope disclosed herein aids theapplication of such sutures. After application of the purse string, theanoscope is removed and a surgical stapler can be inserted into the analcanal. One such stapler which can be utilized, for example, is disclosedin commonly assigned copending application Ser. No. 12/550,443, filedAug. 31, 2009 (the “443 application”), the entire contents of which isincorporated herein by reference. The stapler is also shown in FIG. 8 ofthe present disclosure. As described in that application, the surgicalstapler 10 includes a handle assembly 12, a central body portion 14 anda distal head portion 16. Head portion 16 includes an anvil assembly 18and a shell assembly 20. Handle assembly 12 includes a stationary handle22, a firing trigger 24, an approximation knob 26, an indicator assembly28, and a lockout mechanism 30. Approximation knob 26 functions toretract and advance a drive screw 32 and anvil retainer (connected byconnector 38 via screws 60, 62) to advance or retract anvil assembly 18in relation to cartridge assembly 20. Firing trigger 24 functions toadvance a pusher link 34 to eject staples from shell assembly 20advanced by pusher fingers 104. Shell assembly includes cylindricalportion 98. Each of the components of handle assembly 12 identifiedabove are substantially as described in the '443 application and U.S.Pat. No. 7,303,106 (“'106 patent”). The '106 patent is incorporatedherein in its entirety by reference. Accordingly, these components andassemblies are not described in detail herein.

As discussed above, the stapler 10 is particularly suitable for use insurgical procedures for treating colon prolapse or hemorrhoids. Duringsuch procedure, an access port can be inserted into the anus tofacilitate access to the prolapsed colon or hemorrhoids. Next, a pursestring suture (not shown) is placed into, above or in the vicinity ofthe colon prolapse and the anvil assembly 18 is inserted through theaccess port into the anus and rectum. Bulbous member 96 functions toallow smooth passage of anvil assembly 18 past the purse string suture.Thereafter, a purse string suture 32 is placed through anvil shaft orcenter rod 64 in one of holes 78 a, 78 b 78 c. Holes 78 arelongitudinally spaced along shaft 64 such that the amount of tissuedrawn into the shell assembly 20 can be controlled by properly selectingthe hole 78 to which the purse string suture is inserted. A greateramount of tissue will be drawn into shell assembly 20 by attaching thepurse string suture to the proximalmost hole 78. Anvil assembly 18 andshell assembly 20 are then approximated via knob 26 to draw theprolapsed colon into shell assembly 20.

When surgical stapler 10 is fully approximated, firing trigger 24 can beactuated or fired in a manner described in the '106 patent to staple,sever and allow removal of a portion of the prolapsed colon. Thereafter,stapler 10 is removed from the anus with the excised tissue containedwithin a receptacle of pusher back 100 within shell assembly 20.

FIGS. 1 and 2 illustrate the components of a preferred embodiment of theanoscope kit 10 of the present disclosure useful for hemorrhoid or othersurgical procedures including facilitating application of purse stringsutures. Kit 10 includes a dilator 20 with a dilating tip 22 and ananoscope 40. The dilator 20 is shown in FIG. 1 inserted within theanoscope 40. Anoscope 40 can optionally be composed of transparentmaterial to facilitate visualization of the surgical site, e.g. thehemorrhoidal tissue and adjacent tissue when used in a hemorrhoidectomyprocedure.

Dilator 20 includes a proximal portion or region 22, an intermediateportion or region 24 and a distal portion or region 26. Distal portion26 includes an enlarged distal head 30, preferably substantially conicalin configuration, which has a dilating tip 22 to aid insertion of theanoscope 40. The intermediate portion 24 has a transverse dimension,e.g. diameter, smaller than the largest diameter of the head portion 30,thus forming a reduced diameter region proximal of the lip of the distalhead 22. A transition surface 28 joins intermediate portion 24 withenlarged head 30. In a preferred embodiment, transition surface 28 isangled toward the intermediate portion 24 to form a ramped surface asdescribed below. The dilator 20 is removably positioned in the anoscope40; its positioning within the anoscope 40 aiding insertion of theanoscope 40 through the anus and into the anal canal.

Anoscope 40 has a proximal portion or region 42, an intermediate portionor region 44 and a distal portion or region 46. The proximal portion 42includes a flange 48 which provides a stop to prevent full insertion ofthe anoscope 40 into the anal canal. This is shown for example in FIG. 3wherein the transverse dimension of the flange 48 exceeds the dimensionof the anal opening; the inner surface 47 of flange 48 contacting thetissue region T adjacent the anal opening.

Extending from the inner surface 47 of flange 48 are a plurality offingers 50. Fingers 50 are composed of flexible material to enable thefingers to flex during removal of the dilator 20 as discussed below. Thefingers 50 are spaced apart forming gaps 55 therebetween to facilitateapplication of purse string sutures around a 360 degree area as thetissue, e.g. hemorrhoid tissue, can be accessed through the gaps 55between the fingers 50. Thus, purse string sutures can be applied to thenecessary tissue, e.g. hemorrhoidal tissue, without rotation of theanoscope 40. Note that for clarity, only some of the fingers arelabeled, it being understood that the unlabeled fingers havecorresponding parts.

Fingers 50 terminate in distal tips 52. After extending inwardly fromflange 48, the fingers 50 extend substantially parallel to alongitudinal axis of the anoscope and the free distal ends of thefingers extend substantially parallel to the longitudinal axis of theanoscope. The fingers 50 as shown extend longitudinally in a plane withthe distal tip 52 preferably lying substantially in the same plane asthe intermediate regions 54 of the respective finger. Stated anotheraway, the distance between the intermediate portions of opposing fingers50 and the distal portions of those fingers remains substantially thesame.

The distal tips 52 of the fingers preferably have an angled or rampedsurface 56. This angled surface corresponds in angle to the rampedsurface of transition surface 28 of dilator 20. Thus, a substantiallyflush and smooth surface is formed as the fingers 50 (or at least aportion thereof) lie on the reduced diameter portion (proximal of thedistal head 22) of the dilator 20. Stated another away, when the dilator20 is positioned within the anoscope 40, the transverse dimension of thefinger region is substantially equal to the largest outer dimension ofthe dilator 20, i.e. the outer dimension of the head portion 30. Thisprovides a smooth surface for insertion. By abutting the lip of thedistal head 22, the distal tips 52 of the fingers 50 are shielded by thelip to prevent flexing at the tips during insertion.

Use of the anoscope/dilator kit of the present disclosure is shown inFIGS. 3-6. As shown in FIG. 3, the dilator is positioned within theanoscope 40 and positioned within the anal canal C. As shown, the angledsurface 56 of fingers 50 abut the respective ramped surface 28 of thedilator 20, terminating flush with the lip of the distal head. Thismating of the surfaces creates a smooth insertion surface as shown inFIG. 3, with the lip shielding the distal end of the fingers 50 toreduce flexing of the fingers 50 during insertion. After insertion ofthe anoscope 40 with the aid of the dilator 20 and dilating tip 22, thedilator 20 is removed. As shown in FIG. 4, retraction (withdrawal) ofthe dilator 20 in the direction of the arrow, cams the fingers 50outwardly, as the ramped surface 56 slides past the ramped surface 28 ofthe dilator. This outward flexing of the fingers 50 continues, as shownin FIG. 5, until the dilator 20 is withdrawn to the position of FIG. 6.The dilator 20 is then completely removed from the anoscope 40, with theanoscope 40 left in place for insertion of instrumentation to applypurse string sutures. As noted above, purse string sutures can beapplied to the tissue by accessing the tissue through the gaps 55between the fingers 50.

In an alternative embodiment shown in FIG. 6A, the fingers 150 of theanoscope 140 taper inwardly (in a distal direction) along their lengthso that the transverse dimension of the fingers at the distal region,e.g. dimension T1, is less than the transverse dimension at the proximalregion, e.g. dimension T2. Similarly, the dilator 120 can be taperedinwardly in a distal direction in the region proximal of the enlargeddistal head 122. The angled surfaces of fingers 150 abut the rampedsurface 128 of the dilator in the same manner as in the embodiment ofFIG. 1. Also, the enlarged head 122 has a cross-sectional (transverse)dimension T3 greater than the transverse dimension of the fingers at thedistal end (T1) (to form a lip to shield the tips) but less than thetransverse dimension at the proximal end (T2). In this manner, after thedilator 120 is withdrawn a sufficient distance within the anoscope 140,the dilator can be more easily removed as the enlarged head 122 reachesthe larger transverse dimension of the fingers 150 and can more freelyslide through the anoscope 140 as deflection of the fingers 150 is nolonger necessary. In preferred embodiments, the dimensions providedwould be such that when the dilator is removed one half way orthree-quarters of the way through the anoscope, it becomes in clearanceand the fingers no longer need to deflect, especially down near the basewhere the dilator would be stiffer. Other distances are alsocontemplated.

Note that optionally a port can be provided such as shown in FIG. 7.Port 70 has an opening dimensioned to receive the anoscope 40 (andinserted dilator 20) and wings 72 with suture holes 74 for attachment tothe skin of the patient.

In use, the anoscope 40 (or anoscope 140) with dilator 20 (or dilator120) positioned therein is inserted within the port 70 for access to theanal canal. That is, the anoscope 40 is positioned coaxially within port70 and obturator 20 is positioned coaxially within anoscope 40. Theunit, containing the three coaxial components, is inserted transanally.After insertion of the components, the obturator 20 is removed, leavingthe anoscope 40 extending through port 70. A suture (not shown)extending through holes 74 attaches the port 70 to the patient's body.After removal of the obturator 20, a purse string suture is placed bythe surgeon via a suture holder extending through the gaps 55 betweenthe fingers 50 of anoscope 40. After the sutures are placed, theanoscope 40 is removed from the port 70 and the patient's body, leavingthe port 70 in place to provide a passageway for instrumentation such asthe hemorrhoid circular stapler described above. The staplinginstrument, e.g. instrument 10 described above, can be inserted throughthe port 70 and attached to the anvil assembly. The anvil is thenapproximated and the instrument handle 24 actuated to fire the staples.After staple firing, the instrument is at least partially unapproximatedand the instrument and attached anvil are withdrawn. It should beappreciated that these three components (anoscope, dilator and port) canbe used for hemorrhoid surgery, treatment of colon prolapse as well asother surgical procedures.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplifications ofpreferred embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1. An anoscope kit comprising: an anoscope having a proximal portion, adistal portion, and a plurality of spaced apart fingers having freeends; and a dilator removably positionable within the anoscope to aidinsertion of the anoscope, the dilator having a proximal region, anintermediate region and a distal region, the distal region including anenlarged distal head, and a ramped surface extending from the enlargeddistal head toward the intermediate region, the intermediate regionhaving an outer surface to contact the fingers of the dilator.
 2. Theanoscope kit of claim 1, wherein the fingers extend substantiallyparallel to a longitudinal axis of the anoscope and the free ends of thefingers extend substantially parallel to the longitudinal axis of theanoscope.
 3. The anoscope kit of claim 1 wherein the free ends of thefingers lie in substantially the same plane as an intermediate portionof the respective finger.
 4. The anoscope kit of claim 1, wherein theanoscope includes a flange at the proximal portion thereof and thefingers extend inwardly from the flange and then extend substantiallyparallel to a longitudinal axis of the anoscope.
 5. The anoscope kit ofclaim 1, wherein the free ends of the fingers have an angled surfaceconfigured to mate with the ramped surface of the dilator.
 6. Theanoscope kit of claim 1, wherein a transverse dimension of the anoscopeat the region of the fingers is substantially equal to a largesttransverse dimension of the distal head of the dilator.
 7. The anoscopekit of claim 1, wherein distal tips of the fingers are positionedproximal of the distal head of the dilator during insertion of theanoscope.
 8. The anoscope kit of claim 1, wherein the fingers extendinwardly such that a first transverse dimension of the anoscope adjacenta distal end of the fingers is less than a second transverse dimensionof the anoscope adjacent a proximal end of the fingers.
 9. The anoscopekit of claim 8, wherein a transverse dimension of the enlarged head isgreater than the first transverse dimension and less than the secondtransverse dimension of the anoscope.
 10. The anoscope kit of claim 9,wherein the dilator is tapered inwardly toward the distal head and thefingers are tapered inwardly toward the distal portion.
 11. The anoscopekit of claim 1, further comprising a port dimensioned to receive theanoscope.
 12. In combination an anoscope and dilator, the combinationcomprising a dilator having a distal head forming an enlarged headregion, an intermediate region having an outer surface configured toabut fingers of the anoscope, and a transition surface from the distalhead to the intermediate region, the anoscope having a plurality offingers separated to form gaps therebetween, at least a portion of thefingers dimensioned to lie on the transition surface and on theintermediate region of the dilator.
 13. The combination of claim 12,wherein a distal tip of the fingers lies on the transition surface ofthe dilator and the transition surface is a ramped surface.
 14. Thecombination of claim 13, wherein distal tips of the fingers have anangled surface engaging the ramped surface of the dilator when thedilator is positioned within the anoscope.
 15. The combination of claim14, wherein the anoscope includes an enlarged proximal region creating astop for insertion of the anoscope into an anal canal.
 16. Thecombination of claim 13, wherein upon withdrawal of the dilator from theanoscope, the enlarged head flexes fingers of the anoscope outwardlyaway from a longitudinal axis of the anoscope.
 17. The anoscope kit ofclaim 12, wherein the fingers extend inwardly such that a firsttransverse dimension of the anoscope adjacent a distal end of thefingers is less than a second transverse dimension of the anoscopeadjacent a proximal end of the fingers, and a transverse dimension ofthe enlarged head is greater than the first transverse dimension andless than the second transverse dimension.
 18. A method of inserting ananoscope comprising: providing a dilator having an enlarged dilatingdistal head forming a lip; providing an anoscope having a plurality offingers extending substantially parallel to a longitudinal axis of theanoscope; inserting the dilator into the anoscope; and advancing thedilator and anoscope into the anal canal wherein distal tips of thefingers abut the lip to thereby reduce flexing of the fingers duringanoscope insertion.
 19. The method of claim 18, further comprising thestep of removing the dilator from the anoscope after insertion of theanoscope to the desired position within the anal canal.
 20. The methodof claim 19, wherein the step of advancing the dilator and anoscopeincludes the step of inserting the anoscope through a port.